Insights On Quality Assurance

1. Filling Line Nitrogen Purge Qualification In Manufacturing 6/3/2020

   A client had an existing filling line and wanted to optimize the nitrogen purge process to decrease headspace oxygen levels to 2%. In addition, frequent line stoppages resulted in a need to identify and reject high oxygen vials that had lost the nitrogen headspace during the stoppage. A purging process qualification study was performed using rapid non-destructive headspace oxygen analysis in an at-line set-up with samples being measured immediately from the line.

2. Container Closure Integrity Testing Technologies - PTI Packaging Technologies & Inspection 9/2/2020

   PTI-Packaging Technologies & Inspection is headquartered in Hawthorne, New York, a Westchester county community close to New York City. We are a team of engineers, scientists and professionals serving the packaging industry as a leading equipment manufacturer of package inspection equipment. PTI’s inspection technologies are deterministic test methods that produce quantitative test result data. Our technologies conform to ASTM and other regulatory standards. We specialize in offering our customers the entire solution including test method development and packaging inspection equipment validation. PTI installations have been successful in globally transferable and validated test methods.

3. Quality Stability Testing: Oxygen Monitoring During Shelf Life 6/3/2020

   A manufacturer of a syringe product received complaints about discolored product that was nearing the end of shelf life. A root cause investigation was started and product syringes were put on stability. The headspace oxygen levels were monitored over time. The laser-based headspace analysis proved to be a useful tool to check package integrity and for the presence of reactive headspace gases that can degrade the formulation.

4. High Potency Fill Line 6/17/2021

   Whether it's a liquid or lyophilized product, we provide capacity, quality, and expertise to ensure a stable supply of your promising therapeutics.

5. QRM For Filter Integrity Testing: Complying With EMA's Future Annex 1 10/21/2020

   Quality Risk Management (QRM) is a systematic process for dealing with risks to the quality of a pharmaceutical product throughout its lifecycle. Although QRM is not new, the regulatory focus on QRM will increase with the arrival of Annex 1 of the EMA. Integrity testing of sterile filters is a key focus of QRM as it is a fundamental element of sterility assurance. This article points out the insufficiency of traditional QRM for filter integrity testing and advocates a comprehensive approach that allows the identification and avoidance of possible errors.

6. What Are GxPs And How Do They Shape The Quality Of Your Pharmaceutical Product? 5/4/2021

   Understanding and following GxPs helps to mitigate crucial business risk and improve product quality. Pharmaceutical companies should apply GxPs and the best scientific technology in their quality management systems.

7. A Fill Finish Manufacturing Partner With Resources, Solutions, And Agility 6/1/2021

   We offer a unique range of formulation and aseptic filling in vials, prefilled syringes, or cartridges to address production needs that span from small early stage clinical products to larger scale commercial products.

8. A Guide To Weigh Cell Technologies For Food And Pharma Industries 7/28/2020

   For parcel processing, as well as food and healthcare packaging, recent technology advancements have made in-motion weighing operations more precise and profitable. The latest and greatest catchweighers and checkweighers incorporate weigh cells featuring Electro-Magnetic Force Restoration, or EMFR. In addition, combining EMFR with AVC (Active Vibration Compensation) enables accurate product weight measurements.

9. Understanding Risks Of Biologic Drugs And Injectable Drug-Device Combination Products 8/4/2021

   As the benefits of delivering biologic drugs as part of a combination product platform are realized, this self-administration trend will continue to grow. From a regulatory perspective, the use of a risk-based approach is foundational.

10. Analysis Of Laboratory Nitrile Gloves: From Pores To The Surface 10/7/2020

    The humble rubber glove is usually the first line of protection for any person working with toxic, hazardous and contagious materials or environments. While everyone agrees on their universal use, very little attention is paid to the type of material, surface topography or pore size distribution of the glove itself. Here we describe an approach where the use of multiple techniques has enabled a complete physical characterization of the rubber glove material.